truvada

Generic: emtricitabine and tenofovir disoproxil fumarate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name truvada
Generic Name emtricitabine and tenofovir disoproxil fumarate
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

emtricitabine 200 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2112
Product ID 68071-2112_1d609fda-9b9e-40b3-e063-6294a90a63b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021752
Listing Expiration 2026-12-31
Marketing Start 2004-08-02

Pharmacologic Class

Established (EPC)
human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]
Chemical Structure
nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680712112
Hyphenated Format 68071-2112

Supplemental Identifiers

RxCUI
476556 639888
UPC
0368071211238
UNII
G70B4ETF4S OTT9J7900I
NUI
N0000175462 M0015066 N0000009947

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name truvada (source: ndc)
Generic Name emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Application Number NDA021752 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2112-3)
source: ndc

Packages (1)

68071-2112-3 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2112-3)

Ingredients (2)

emtricitabine (200 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

Truvada ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d609fda-9b9e-40b3-e063-6294a90a63b9", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "upc": ["0368071211238"], "unii": ["G70B4ETF4S", "OTT9J7900I"], "rxcui": ["476556", "639888"], "spl_set_id": ["46e06df0-654d-43cc-e054-00144ff8d46c"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2112-3)", "package_ndc": "68071-2112-3", "marketing_start_date": "20170124"}], "brand_name": "Truvada", "product_id": "68071-2112_1d609fda-9b9e-40b3-e063-6294a90a63b9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]"], "product_ndc": "68071-2112", "generic_name": "emtricitabine and tenofovir disoproxil fumarate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Truvada", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "NDA021752", "marketing_category": "NDA", "marketing_start_date": "20040802", "listing_expiration_date": "20261231"}